Positive opinion for Promixin

Published: 23-Feb-2004

Profile Therapeutics has received positive opinion for Promixin, its inhaled antibiotic used to treat Pseudomonal lung infections in patients with cystic fibrosis


Profile Therapeutics has received positive opinion for Promixin, its inhaled antibiotic used to treat Pseudomonal lung infections in patients with cystic fibrosis

Positive opinion was received from the respective regulatory authorities in eight of the fourteen markets in which it submitted, and therefore anticipates full regulatory approval in these markets over the coming months.

The markets where positive opinion was given are: Italy; Spain; Ireland; Germany; Greece; Belgium; Luxembourg and Denmark. Profile estimates that these markets account for approximately 50% of the European market for inhaled colistin in cystic fibrosis patients. Profile currently does not intend to generate the additional data required to gain approval from the remaining six markets. Promixin is already sold in the UK.

Commenting on the announcement, John Lisle, chief executive of Profile, said: 'This is an important step forward in the development of our drug delivery business and we look forward to receiving marketing authorisations and entering the reimbursement discussion process over the coming months. We are continuing our discussions with marketing partners in these territories.'

  

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